The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Marquette Pediatric Defibrillation/pacing Pads.
Device ID | K911662 |
510k Number | K911662 |
Device Name: | MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS |
Classification | Dc-defibrillator, Low-energy, (including Paddles) |
Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Contact | Sandra Schick |
Correspondent | Sandra Schick MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Product Code | LDD |
CFR Regulation Number | 870.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-12 |
Decision Date | 1991-10-10 |